Access to the Swiss medical device market Basel (CH), Münster (DE), 09/21/2021 – Diapharm has set up a branch office in Switzerland, allowing it to act as a Swiss authorised representative for registration procedures and safety-related matters for the marketing and distribution of medical devices within the country’s borders. Procedural changes were made in May 2021 in relation to the marketing and distribution of medical devices in Switzerland. According to the Swiss Medical Devices Ordinance (MedDO), only Swiss companies are permitted to register medicinal products and medical devices with Swissmedic, the Swiss regulatory and authorisation body. The rules apply to products newly placed on the market and legacy devices already on the market prior to May 2021, albeit with a transitional period in the latter case. more >>
Handling Brexit: Diapharm sets up UK branch for medical devices London, 12/22/2020 – To give manufacturers of medical devices continued access to the British market after Brexit, the consultancy and service provider Diapharm is establishing a new branch in the UK effective 1 January 2021. From there, Diapharm will act as a UK Authorised Representative for clients from the European Union and ensure cooperation with the authority responsible for approvals in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA). more >>
Diapharm ensures MDR conformity of medical devices: one-stop shop for reassessments of existing products Münster, Lübeck, 09/09/2020 – Diapharm (www.diapharm.com) is committed to maintaining safe and effective medical devices under the new Medical Devices Regulation (MDR). The company presents an integrated solution for the conformity assessments in accordance with the MDR requirements. Diapharm will be focusing in particular on existing devices whose conformity assessment to date does not comply with the new requirements. more >>
Dr Guido Middeler takes over management of HÄLSA Pharma GmbH Lübeck, 01/31/2020 – Dr Guido Middeler has taken over management of HÄLSA Pharma GmbH and its locations in Lübeck and Münster with immediate effect. The company is a subsidiary of Diapharm (www.diapharm.com), the pharmaceutical consultancy. HÄLSA Pharma performs regulatory functions for a wide range of customers from the pharmaceutical industry with regard to the approval and marketing of medicinal products and medical devices. From the application as a pharmaceutical company to batch releases and the safeguarding of vigilance requirements, HÄLSA offers an all-round carefree package for medicinal products as well as for medical devices. In addition, HÄLSA assumes full responsibility as a legal manufacturer and acts as the European Authorised Representative on behalf of its clients. more >>
Dr Thilo Sandner sets sights on growth for Diapharm Münster, 01/14/2020 – The pharmaceutical consulting company Diapharm (www.diapharm.com) is setting its sights on growth. “The rapidly changing pharmaceutical market calls on us to be agile,” says Dr Thilo Sandner, principal shareholder and General Manager of Diapharm. As a result, the company plans to significantly increase the number of employees once again over the course of this fiscal year. The company already employs nearly one hundred experts to develop strategies for healthcare products and to provide market access and maintenance support. more >>
Chinese food supplement manufacturers learn from Diapharm in Frankfurt Frankfurt, 11/13/2019 – A delegation from the China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) visited Diapharm’s location in Frankfurt to learn about European market requirements for food supplements and food for special medical purposes. Diapharm (www.diapharm.com), a pharmaceutical consulting company, is an official cooperation partner of the CCCMHPIE and helps Chinese manufacturers to enter the European market. More than 2,500 member firms came together under the umbrella of the CCCMHPIE to foster dialogue with state authorities and international partners. more >>
Change to Diapharm’s shareholder structure: Dr Thilo Sandner takes over responsibility Münster, 11/11/2019 – Dr Thilo Sandner has taken over a majority stake in pharmaceutical consultancy Diapharm (www.diapharm.com). The company announced the change in Münster (Germany). The experienced business consultant has been managing the consulting firm with offices in Germany, Austria, the Netherlands and China since the start of 2019 as General Manager together with pharmacist Ralf Sibbing and is now also the principal shareholder. more >>
Diapharm teams up with GMTCM Park to bring TCM products to Europe Macao (CN), Münster (DE), 10/01/2019 – Ralf Sibbing, the Managing Partner of Diapharm GmbH Co. & KG (www.diapharm.com) signed a strategic partnership cooperation agreement with Guangdong-Macau Traditional Chinese Medicine Technology Industrial Park Development Co., Ltd. (GMTCM Park) at the 2019 Traditional Medicine International Cooperation Forum in Macao, China. The event was co-hosted by the Government of the Macao Special Administrative Region, the State Administration of Traditional Chinese Medicine of the People‘s Republic of China, and GMTCM Park. Ralf Sibbing was invited to give a speech at the Business Matching Forum with the topic “EU Market Analysis of Food Supplements & Traditional Herbal Medicinal Products.“ more >>
First natural, herbal medicine for overweight patients registered in Germany and available throughout the EU Muenster, 06/06/2019 – The German Federal Institute for Drugs and Medical Devices (BfArM) has granted pharmaceutical consultancy Diapharm the first traditional herbal registration for a medicinal product complementing a weight loss diet for overweight patients. The seaweed powder with 130 mg of bladderwrack (Fucus vesiculosus) is available in Germany in the form of a plant-based film-coated tablet for the first time. The recommended dosage is one film-coated tablet with water twice a day, two hours before meals. more >>
Diapharm certified as a European Authorised Representative for medical devices from third states Lübeck (DE), 03/19/2019 – In addition to its certification for the development, production, final inspection and marketing of medical devices, the pharmaceutical service provider Diapharm (www.diapharm.com) has now also been EN ISO 13485:2016 certified as a European Authorised Representative (EAR or EC REP). European law requires companies based outside the EU that want to market their products in the European single market to appoint an EC REP. Demand for this EAR function has risen dramatically, due in no small part to many companies’ Brexit preparations, as Dr Guido Middeler, Partner and Head of Medical Devices at Diapharm, explains. In all remaining potential Brexit scenarios, the United Kingdom will ultimately become a third state for the remaining EU member countries. more >>
New generation of Diapharm management Münster (DE), 01/30/2019 – Diapharm (www.diapharm.com) has implemented its succession plan by appointing experienced business consultant Dr Thilo Sander as part of the management team. He will lead the pharmaceutical consulting company with immediate effect together with pharmacist Ralf Sibbing. He replaces Diapharm founder Dr Stefan Sandner, who will remain part of the company and be actively involved in shaping its strategic focus. Diapharm is a service provider and consulting firm for the consumer healthcare and pharmaceutical industry. Around 100 employees at seven locations in Germany, the Netherlands, Austria and China provide consulting services to clients in strategic matters, assume responsibility for regulatory, medical and scientific tasks and provide support in the area of quality assurance. more >>
Diapharm Analytics joins the Tentamus Group Oldenburg, Münster, Berlin (Germany), 12/12/2018 – The pharmaceutical laboratory Diapharm Analytics GmbH in Oldenburg, Germany, is joining the Tentamus Group. Ralf Sibbing, General Manager of Diapharm Analytics GmbH, and Dr. Jochen P. Zoller, CEO of Tentamus Analytics GmbH, announced the move in Oldenburg. “Even though formalities do not change, since name of the company, the location and staff will remain the same, Diapharm Analytics will henceforth play, with the support of the Tentamus Group, in a new league. This will allow Diapharm Analytics to offer our clients an even wider range of expertise and competences,” Diapharm General Manager Ralf Sibbing said, referring to the company’s successful entry into the Tentamus Group. more >>
Bert Verhage has left Diapharm B.V. with immediate effect Breda (NL), Münster (DE), 10/02/2018 – Bert Verhage has left the Dutch Diapharm subsidiary Diapharm B.V. (www.diapharm.nl) in Breda with immediate effect from 1 October 2018. Ralf Sibbing, General Manager of the Diapharm parent company in Germany, will take over Bert Verhage’s responsibilities as a member of the management team. more >>
Natural medicinal products against menstrual complaints: Yarrow and Shepherd’s purse registered with the BfArM Münster, 09/25/2018 – Diapharm received registrations for two interesting traditional medicinal products used to treat menstrual complaints. The Federal Institute for Drugs and Medical Devices in Germany, BfArM, registered Capsella bursa pastoris (Shepherd’s purse) as the first coated tablet for the reduction of heavy menstrual bleeding in women with regular menstrual cycles. A film-coated tablet of Achillea millefolium (Yarrow) has been newly registered and is used for the symptomatic treatment of minor spasms associated with menstrual periods from age 12. “Demand for such natural herbal remedies is constantly increasing,” says Nicole Sibbing, Director of Diapharm (www.diapharm.com): “The desire of consumers for ‘natural’ medicines is a direct reflection of the transformation of society.” Instead of marketing the pharmacy-only medicinal products by itself, Diapharm licences the products to pharmaceutical companies in Europe so they can expand their own OTC brands. more >>
Diapharm welcomes new EMA location in Amsterdam Breda (NL), Münster (DE), 11/23/2017 – The European pharmaceutical service provider Diapharm (www.diapharm.com) welcomes the EU’s decision to relocate the European Medicines Agency (EMA) to Amsterdam. “The Dutch people have always been open to innovation, and we hope that this spirit will also help guide the EMA’s future decisions,” says Ralf Sibbing, General Manager of Diapharm. Diapharm opened an office in Breda (Netherlands) in March 2017 and hence is optimally equipped to handle the new development. Home to the Benelux offices of companies such as Amgen, Janssen-Cilag, Fagron, Vifor and UCB, Breda is currently on its way to becoming a successful pharmaceutical hub for the region. more >>
Brexit for the Chinese: Diapharm explains volatility in the EU pharmaceutical industry at CPhI China Münster (DE), Shanghai (CN), 07/07/2017 – General Manager of Diapharm Ralf Sibbing discussed the impact of the upcoming Brexit at CPhI China, which took place in Shanghai from 20 to 22 June 2017. His presentation focused on the preparations of Chinese pharmaceutical companies aimed at launching products on the European market. “The volatility caused by the United Kingdom’s upcoming exit from the EU is already having an impact on the decision-making processes of providers from third countries,” Ralf Sibbing remarked in Shanghai. more >>
Diapharm welcomes Dr Thilo Sandner to consulting team Münster (DE), 05/29/2017 – The healthcare consultancy Diapharm (www.diapharm.com) announces the arrival of Dr Thilo Sandner, an experienced business consultant, to its team. Prior to joining Diapharm, Thilo Sandner gained considerable experience in the global Life Sciences team of Charles River Associates (CRA), formerly Cepton Strategies, in their Munich and New York City offices. During his time at CRA, he managed projects on portfolio and commercial strategies, as well as market access. At Diapharm, he will assume a leading role in the strategic management consulting team. more >>
China and Europe foster the internationalisation of TCM Chengdu (CN), Münster (DE), 10/27/2016 – “Europeans think highly of Traditional Chinese Medicine, but so far only a few TCM products have made their way into the EU”, observed Diapharm’s Dr Rainer Kolkmann at the 5th International Conference on the Modernization of Traditional Chinese Medicine (TCM) in Chengdu, China. But Kolkmann also said that the European Medicines Agency and its Committee on Herbal Medicinal Products, HMPC, are “open-minded” to TCM products coming to Europe: “The harmonisation of assessment practices for herbal substances of non-European origin is explicitly included in their work programme.“ In his speech, the Head of Product Development at one of Europe’s leading regulatory service providers (www.diapharm.com) explained how to successfully register TCMs in the European Union. Dr Rainer Kolkmann had been invited as a foreign vice president to the conference’s TCM innovation panel. The conference with 1,500 participants took place on 24-25 October in Chengdu, the capital of Sichuan Province, China. more >>
First successful traditional-use registration for a product containing St John’s Wort and Valerian Oldenburg (DE), Münster (DE), 09/26/2016 – The pharmaceutical service provider Diapharm has succeeded in obtaining traditional-use registration for a combination product containing St John’s Wort and Valerian extracts for the treatment of mental exhaustion (fatigue) and related sleep disturbance. Until now, the time-consuming marketing authorisation process was the only path to being able to market products containing St John’s Wort and Valerian. For the first time, Diapharm has been able to register with the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) a combination product consisting of both active pharmaceutical ingredients (APIs) with an appealing indication and a consumer-friendly dosage. The combination product is available for licensing. more >>
Diapharm achieves DCP registration in seven countries for a traditional herbal medicine containing St John’s Wort and Black Cohosh Münster (DE), 08/18/2016 – Seven EU member states have approved a new traditional herbal medicinal product (THMP) containing Hypericum (St John’s Wort) and Cimicifuga racemosa (Black Cohosh). Idelyn will be marketing the THMP “for the relief of symptoms of the menopause, including hot flushes, night sweats, also profuse sweats, slightly low mood and mild anxiety based on traditional use only”, which was developed by pharmaceutical services provider Diapharm, in Hungary, Bulgaria, Estonia, Lithuania, Romania, Slovakia and the Czech Republic. These seven countries opted for registration in what is known as a voluntary decentralised procedure (DCP). Diapharm has also prepared further national authorisation applications on behalf of Idelyn. more >>
Diapharm fortifies its ties to China Bonn (DE), Münster (DE), Shanghai (CN), 08/08/2016 – Diapharm, the global service provider and consulting firm for the pharmaceutical industry (www.diapharm.com), is intensifying its business with clients from China. It recently accompanied Huasun Group Pharmaceutical Factory (China), along with Dr. Mei Wang of SU BioMedicine (Netherlands, a TNO company), to the German medicines authority BfArM for a scientific advice meeting on their Sanchi-tongshu capsules. The product is on the way to become the first Traditional Chinese Medicine, or TCM, to be registered via a full application in Europe. more >>
Diapharm strengthens pharmacovigilance team with Dr Hartmut Kley Münster (DE), 01/20/2016 – Dr Hartmut Kley has joined Diapharm (www.diapharm.com) as Senior Manager Pharmacovigilance, marking an additional expansion of the pharmaceutical service provider’s activities in the field of drug safety. The company monitors and evaluates the risk/benefit profile of medicinal products on an ongoing basis on behalf of its clients, compiles the required safety reports (PSURs, PBRERs), conducts pharmacovigilance audits and assumes responsibility for a number of roles, such as qualified person for pharmacovigilance. “We see great potential in this field,” says Diapharm founder Dr Stefan Sandner. “As a result, we are particularly pleased to have been able to attract an extremely experienced consultant and auditor such as Dr Hartmut Kley.” more >>
Diapharm now provides over 500 GMP audit reports Münster (DE), 12/11/2015 – The pharmaceutical service provider Diapharm’s third-party audit service (uk.diapharm.com/audits/) has now exceeded the mark of 500 current GMP audit reports. On behalf of the pharmaceutical industry, auditors check on site whether suppliers of active pharmaceutical ingredients (APIs) worldwide are complying with Good Manufacturing Practices. From the manufacturing of acetylcysteine in Spain to zolmitriptan in India, almost all of Diapharm’s audit reports are available for purchase. A small amount of audits are performed exclusively for individual clients. more >>
Register and Market High Quality Chinese Medicines in Europe Shanghai (CN), Muenster (DE), 06/24/2015 – The European Union is one of the most important pharmaceutical markets globally. The market size of the EU-15 countries alone reached USD 134 billion in 2013. In 2014, the pharmaceutical trade between China and Europe reached USD 33.2 billion, with finished medicinal products accounting for USD 9.3 billion. As the export amount to EU was only USD 450 million, the composition of trade needs to be upgraded and enhanced. more >>
Diapharm Shanghai to strengthen pharmaceutical exchange at its new offices in Shanghai Shanghai (CN), Münster (DE), 06/11/2015 – Diapharm’s offices in China (http://cn.diapharm.com) are moving: “Our activities in Asia are developing very positively,” says General Manager Ralf Sibbing. “We will continue to expand this presence with our new office on XianXia Road in Shanghai.” Diapharm supports medicinal product manufacturers in the marketing authorisation and maintenance of medicinal and healthcare products in its role as a consultancy firm and a pharmaceutical service provider. In China, Diapharm is a point of contact for the roughly 2,400 member companies of the China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE). more >>
